Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Homeless Women

May 6, 2014 updated by: RAND

Cognitive Behavioral Therapy for Homeless Women With Post-Traumatic Stress Disorder (PTSD)

This study will determine the effectiveness of cognitive behavioral therapy in treating post-traumatic stress disorder in homeless women.

Study Overview

Detailed Description

Exposure to traumatic events may lead to mental health problems, such as post-traumatic stress disorder (PTSD). PTSD is a type of anxiety disorder that is characterized by the presence of persistent frightening thoughts and memories of the traumatic event. Additionally, people with PTSD often feel emotionally numb, and they may experience sleep problems or be easily startled. Homeless people, in particular, are at risk for experiencing a variety of traumas. Homeless women tend to experience more traumatic events and develop PTSD at higher rates than housed women. Although effective treatments for PTSD are available, homeless women are unlikely to seek them out. There is a need for PTSD treatment approaches that are specifically designed for these women. This study will develop a cognitive-behavioral therapy treatment that will be adapted to best serve the needs of homeless women. The study will then determine the therapy's effectiveness in treating a group of homeless women with PTSD.

This study will consist of three phases. The first phase will be used to gather and analyze information about PTSD in homeless women and methods of treating the disorder in this population. Focus groups consisting of homeless women, shelter directors, case managers, and mental health service providers will be used to obtain the necessary information. Phase two of this study will consist of developing an adaptation of an existing PTSD treatment manual to make it relevant to the lives of homeless women. The third and final phase of this study will recruit 32 homeless women with symptoms of PTSD, and who did not participate in either of the first two phases of the study. Participants in this 4-week study will be randomly assigned to receive either the adapted cognitive behavioral therapy treatment or no treatment at all (assessment-only). The treatment group will attend twice weekly sessions for a total of 4 weeks. All participants will be evaluated immediately prior to the start of treatment and 1 week after treatment ends. Outcomes will include PTSD symptoms and depression symptoms.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles County, California, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Sub-diagnostic threshold PTSD symptoms
  • Currently resides in a transitional homeless shelter in Los Angeles County
  • Trauma that is related to PTSD symptoms occurred at least 1 month prior to study entry
  • Understands, speaks, and reads English
  • Planned departure date from the shelter is at least 1 month after study entry

Exclusion Criteria:

  • Significant cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive adapted cognitive behavioral therapy treatment
Adapted CBT is a group treatment for PTSD and will occur two times per week for 4 weeks. The sessions will last 90-minutes and will be led by a therapist and co-therapist.
No Intervention: 2
Participants will receive no treatment for the course of the study; they will be offered courtesy PTSD 5 weeks after the experimental intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PTSD symptoms
Time Frame: Measured at Week 4
Measured at Week 4
Depression symptoms
Time Frame: Measured at Week 4
Measured at Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Suzanne Wenzel, PhD, RAND

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

July 14, 2006

First Submitted That Met QC Criteria

July 17, 2006

First Posted (Estimate)

July 18, 2006

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • R34MH076099 (U.S. NIH Grant/Contract)
  • DSIR 82-SEMS (Other Identifier: National Institute of Mental Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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